MODIFIED SPANTRON FRAME FREEZE— 510(k) K895546

Substantially Equivalent

Spantron, Inc.

FDA 510(k) clearance K895546 for MODIFIED SPANTRON FRAME FREEZE, Substantially Equivalent on 1989-11-13. Applicant: Spantron, Inc..

Clearance details

Applicant: Spantron, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1989-09-13
Decision date: 1989-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.